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Also known as Diclofenac Diethylamine (DDEA) gel
Diclofenac Diethylamine · 1 trial · 1 indication
Synovial tissue was collected during surgery (participant's scheduled arthroplasty of the target knee on which study treatment was applied). Samples were analyzed for diclofenac levels using a validated bio analytical method in compliance with the applicable standard operating procedures of the bioanalytical laboratory. Synovial tissue diclofenac concentration was summarized by treatment group. Number of participants with diclofenac concentration values that were below the limit of quantification (LOQ) were replaced by 0 for placebo group. The geometric mean was calculated with a two-sided 95% confidence interval assuming data on the logarithmic scale were normally distributed.
Synovial fluid was collected during surgery (participant's scheduled arthroplasty of the target knee on which study treatment was applied). Samples were analyzed for diclofenac levels using a validated bio analytical method in compliance with the applicable standard operating procedures of the bioanalytical laboratory. Synovial fluid diclofenac concentration was summarized by treatment group. Number of participants with diclofenac concentration values that were below the LOQ were replaced by 0 for placebo group. The geometric mean was calculated with a two-sided 95% confidence interval assuming data on the logarithmic scale were normally distributed.
| Arm | Type | Description |
|---|---|---|
| Active Treatment | EXPERIMENTAL | In the active treatment arm, DDEA gel will be applied topically at a dose of 4 gram (g) on 400 square centimeter (cm\^2) twice a day for 7 days to the target knee (the knee planned for arthroplasty surgery). |
| Placebo Control | PLACEBO_COMPARATOR | In the placebo control arm, placebo gel will be applied topically at a dose of 4 gram (g) on 400 square centimeter (cm\^2) twice a day for 7 days to the target knee (the knee planned for arthroplasty surgery). |
| Name | Type | Description |
|---|---|---|
| Diclofenac Diethylamine (DDEA) gel | DRUG | Diclofenac Diethylamine (DDEA) gel consists of 2.32% DDEA. DDEA gel will be applied twice a day for 7 days topically first and last dose by trained nurse (or designee) at study site and doses in between by a trained nurse at participant's home or other convenient location. Participants will be admitted on the day before the scheduled surgery (Day 7). The last dose of study treatment will be administered at the study site 12 hours (window -1/+3 hrs) prior to arthroplasty surgery.If surgery is delayed by up to 7 days dosing with DDEA gel twice daily can continue up to 14 days. If the surgery is delayed by more than 7 days, the participant should be withdrawn from the study. |
| Placebo gel | OTHER | Placebo gel will be applied twice a day for 7 days topically first and last dose by trained nurse (or designee) at study site and doses in between by a trained nurse at participant's home or other convenient location. Participants will be admitted on the day before the scheduled surgery (Day 7). The last dose of placebo gel will be administered at the study site 12 hours (window -1/+3 hrs) prior to arthroplasty surgery. If surgery is delayed by up to 7 days dosing with placebo gel twice daily can continue up to 14 days. If the surgery is delayed by more than 7 days, the participant should be withdrawn from the study. |
Inclusion Criteria: * Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. * Male and female participants who, at the time of screening, are ≥ 50 years of age. ...
Diclofenac Diethylamine is a small molecule drug developed by GSK plc (ticker: GSK) for the treatment of pain. It is formulated as a gel and is also known as Diclofenac Diethylamine (DDEA) gel. It is currently in Phase 1 clinical development.
Diclofenac Diethylamine is being developed for the treatment of pain. Its only listed indication is pain, and it is being studied in patients with osteoarthritis who are scheduled for arthroplasty. It is not yet approved for any use.
Diclofenac Diethylamine targets PTGS2 and PTGS1. It is classified as an inhibitor of these targets. By inhibiting PTGS2 and PTGS1, it is designed to reduce pain, though its exact mechanism in the gel formulation is still under investigation in Phase 1 trials.
Diclofenac Diethylamine is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical trial evaluating this drug. No other developers or partners are listed for this asset.
Diclofenac Diethylamine is in Phase 1 clinical development. It has not been approved by the FDA or any other regulatory agency. The only recorded trial is a completed Phase 1 study, and no active trials are currently listed.
Diclofenac Diethylamine has been evaluated in one completed Phase 1 trial, NCT03497039. This randomized, double-blind, placebo-controlled study enrolled 47 participants with osteoarthritis scheduled for arthroplasty and was conducted in Germany and the United Kingdom. No active trials are ongoing.
Yes, Diclofenac Diethylamine is also known as Diclofenac Diethylamine (DDEA) gel. The two names refer to the same product. DDEA gel is the formulation name used in the clinical trial, which applied the gel to the knee of subjects with osteoarthritis.